Exercise-induced Paradoxical Vocal Fold Motion Disorder: Clinical Features and Potential Mechanisms

Completed · Not applicable

Conditions studied: Disorder of Vocal Cord

In brief

Exercise-induced paradoxical vocal fold motion disorder (E-PVFMD) - which severely impacts the lives of up to 1 million adolescents in the U.S. annually - is under- or mis-diagnosed in as many as 80% of cases, leading to ineffective, protracted periods of management. Additionally, what makes those with the condition different from those at risk for the condition (e.g., playing sports/engaging in athletic activity within a competitive athletic environment) is unclear. The goals of this proposed study are to address this diagnostic challenge by (1) pursuing a previously published preliminary taxonomic algorithm for the clinical identification and classification of EPVFMD, and by (2) elucidating potential underlying mechanisms driving this clinical presentation. Study outcomes will improve sensitivity and specificity of diagnosis protocols for PVFMD, thereby reducing prevalence of misdiagnosis and improving clinical management in individuals with this disorder in the future. Outcomes will also be used to create preventative care measures for adolescents at risk for the condition.

Key facts

Study ID

NCT02947009

Run by

University of Pittsburgh

People needed

27

Starts

2016-11-01

Expected to finish

2017-07-03

Last updated by the study team

2017-08-14

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adolescents (ages 12-18yo)
• Exercise regularly (at least 40min 3x/week) in competitive athletic environment
• Inclusion criteria specific to E-PVFMD group: report of atypical dyspnea during exertion and associated decrements in athletic performance for more than 2 weeks prior to presentation; Score of > 10/40 on the Dyspnea Index

You may not qualify if…

• Developmental or cognitive disorder precluding ability to follow directions or read instructions
• Behavioral disorder that would disrupt study protocol or potentially affect outcome parameters (e.g., attention-deficit/hyperactivity disorder [ADHD], oppositional defiant disorder [ODD]).
• Neuromuscular disorders affecting the respiratory or phonatory system (e.g., ALS, Myasthenia Gravis)
• Supralaryngeal anatomical defects impeding airflow
• Cardiovascular conditions/disorders (e.g., hypertension)
• Poorly controlled obstructive pulmonary disorders (e.g., asthma)
• Use of the following medications: (a) antihypertensive, (b) cardiovascular, (c) psychotropic
• Identifiable (organic) vocal fold pathology occluding more than a 1/3 of the airway (e.g., lesions, nodules), found on laryngeal examination
• Intolerance to flexible nasoendoscopy
• E-PVFMD group only: absence of signs or symptoms of acute E-PVFMD attack with exercise provocation challenge at maximum exertion at or before the 3minute mark.
• At-Risk group only: Positive signs or symptoms of an acute E-PVFMD attack with exercise provocation challenge at maximum exertion.

Where it is running

• Mass Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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